Title 21: Food and Drugs
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/ PART 870 - CARDIOVASCULAR DEVICES
/ Subpart E - Cardiovascular Surgical Devices / § 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
§ 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
(a) Identification. A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.
(b) Classification. Class II (performance standards).